Systems & Requirements Engineer (w/m/d) – Medizintechnik
Core
Translating regulatory requirements into design inputs and managing the requirements lifecycle for a medical device product.
Role type
Senior Systems & Requirements Engineer (Regulated MedTech)
Builds
A therapy-assistance CT system for minimally invasive medicine
Domain
Medical Technology / Healthcare
Required skills
Systems Engineering, Requirements Engineering, Regulatory Standards (MDR, ISO 13485, IEC 62304, ISO 14971, EN 60601), Risk Management (ISO 14971), Traceability Management, Change Control, Hardware/Software Systems
Preferred skills
Requirements Management Tools (DOORS, Polarion, Jama), Process/QMS Development
Responsibilities
Elicit and structure system/product requirements, Translate regulatory requirements into design inputs, Manage requirements lifecycle (versioning, baselining, change control), Ensure end-to-end traceability, Design risk management per ISO 14971, Moderate trade-offs and prioritize tasks